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Sunday, September 25, 2022

Elite Pharmaceuticals, Inc. (OTCMKTS: ELTP) Steady Run Northbound as Biotech Records Record Revenues & Reverses off $0.023 Lows

Elite Pharmaceuticals, Inc. (OTCMKTS: ELTP) has been moving steadily northbound in recent trading since reversing off $0.023 lows. ELTP made a legendary move back in 2014 to highs over $0.90 per share but has failed to do much since than slowly dropping over the years culminating in recent all-time lows. In the past there was heavy dilution which was a big contributor to teh falling share price but that has stabilized with ELTP only gaining 2 million shares over the past 12 months. 

ELTP has every reason to get noticed by investors at current levels; this is a Company with $7.2 million in the treasury and growing revenues recently reporting $9 million in sales for Q3, 2021, an increase of $2.9 million or 48% as compared to the corresponding period of the prior year, primarily due to stronger sales of Amphetamine IR Tablets and Amphetamine ER Capsules. Net income was an incredible $2.3 million unheard of numbers on the OTC. While the Company does have some convertibles on the books total liabilities are only 9 million. The Company has 11 products currently bringing in revenues and is on track to top $35 million in sales in 2022. 

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Elite Pharmaceuticals, Inc. (OTCMKTS: ELTP) is a specialty pharmaceutical company that develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma.  

The Company’s strategy includes improving off-patent drug products for life cycle management, developing generic versions of controlled-release drug products with high barriers to entry and exploiting our proprietary and patented abuse resistance technologies. Elite occupies a manufacturing, warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ. The 55,000 square foot campus in Northvale, New Jersey operates under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement Agency (“DEA”) registered facility for research, development and manufacturing. 

Elite is focusing efforts on the following areas: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Applications (“ANDAs”); (ii) development of additional generic pharmaceutical products; (iii) development of the other products in our pipeline including the products with our partners; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations; and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations. 

The Company’s focus is on the development of various types of drug products, including generic drug products which require ANDAs as well as branded drug products which require New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Drug Price Competition Act”). 

Elite owns, licenses, contract manufactures or receives royalties from the following products currently being sold commercially:  

  • Phentermine HCl 37.5mg tablets
  • Phendimetrazine Tartrate 35mg tablets
  • Phentermine HCl 15mg and 30mg capsules
  • Naltrexone HCl 50mg tablets
  • Isradipine 2.5mg and 5mg capsules
  • Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets
  • Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules
  • Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets
  • Dantrolene Sodium Capsules 25mg, 50mg and 100mg
  • Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules
  • Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules

Another thing that will help the bottom line is the recent approval from the US Food and Drug Administration (FDA) for doxycycline hyclate 100 mg tablets together with Elite’s co-development partner, Praxgen Pharmaceuticals LLC. Doxycycline hyclate is an antibiotic that is used to treat a wide variety of bacterial infections. 

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ELTP

For years ELTP has been developing its proprietary abuse deterrent utilizing the pharmacological approach to abuse deterrence and consists of a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. SequestOx™ is Elite’s immediate-release Oxycodone Hydrochloride opioid abuse-deterrent candidate which contains sequestered Naltrexone. SequestOx™ comes in 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths of oxycodone.   

In February ELTP announced results for the third quarter of fiscal year 2022 ended December 31, 2021. Consolidated revenues for the Third Quarter were $9.0 million, an increase of $2.9 million or 48% as compared to the corresponding period of the prior year, primarily due to stronger sales of Amphetamine IR Tablets and Amphetamine ER Capsules. Operating profits of $1.8 million, an increase of $0.8 million from the comparable period of the prior year, and net income was $2.3 million. 

On May 11 ELTP announced the appointment of Robert Chen, CPA/MPA, as its Chief Financial Officer (CFO), effective May 16, 2022, succeeding Marc Bregman. Mr. Chen joins Elite with broad experience in financial and operational leadership for life science companies, both private and public, ranging from preclinical development to commercial operations. Mr. Chen brings with him extensive and diversified financial leadership background in the areas of financial reporting, including manufacturing, financial and cost accounting, SEC, GAAP and IFRS, as well as financial planning and analysis. Mr. Chen previously served in roles as CFO, Vice President of Finance, and Corporate Controller primarily in the life sciences sector. Mr. Chen most recently served as Vice President of Finance for KBP Biosciences, a clinical-stage biotech start-up. Mr. Chen also held financial positions with Bradley Pharmaceuticals, Novartis, Victory Commercial Management, Medimetriks Pharmaceuticals, and Taiho Oncology. 

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Currently trading at a $42 million market valuation ELTP is an SEC filer and fully reporting OTCQB. While investors in the Company are demoralized after years of decline at current levels ELTP looks very attractive; ELTP has $7.2 million in the treasury and growing revenues recently reporting $9 million in sales for Q3, 2021, an increase of $2.9 million or 48% as compared to the corresponding period of the prior year, primarily due to stronger sales of Amphetamine IR Tablets and Amphetamine ER Capsules. Net income was an incredible $2.3 million unheard of numbers on the OTC. While the Company does have some convertibles on the books total liabilities are only 9 million. The Company has 11 products currently bringing in revenues and is on track to top $35 million in sales in 2022. Dilution has stabilized for now and ELTP is moving northbound in a hurry under heavy accumulation. We will be updating on ELTP when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ELTP.

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Disclosure: we hold no position in ELTP either long or short and we have not been compensated for this article.

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